Broncochem Cold and Flu Tea Acetaminophen-Phenylephrine Hydrochloride-Chlorpheniramine Maleate 500 mg/13g; 4 mg/13g Granule, For Solution — NDC 65131-0097-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Broncochem Cold and Flu Tea Acetaminophen-Phenylephrine Hydrochloride-Chlorpheniramine Maleate 500 mg/13g; 4 mg/13g Granule, For Solution — NDC 65131-097-12 (Billing 65131-0097-12)

by LABORATORIO MAGNACHEM INTERNATIONAL SRL · 25 PACKAGE in 1 BOX / 13 g in 1 PACKAGE

This is a package of Broncochem Cold and Flu Tea Acetaminophen-Phenylephrine Hydrochloride-Chlorpheniramine Maleate 500 mg/13g; 4 mg/13g Granule, For Solution from LABORATORIO MAGNACHEM INTERNATIONAL SRL, marketed since Sep 2013 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 65131-0097-12
🏷️ FDA NDC (as labeled) 65131-097-12 billing pads the product segment with a zero
This package
Contains13 g in 1 package Pack sizes2 compare ↓
Main listing for product 65131-097 · Also comes in: 13 g 65131-097-53
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 65131-097-12 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
65131 labeler · 097 product · 12 package
Package marketed since
Sep 28, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0805418097532
FDA record last changed
Jul 24, 2026
🚨
Active recall for this product.
Class II · Feb 16, 2024 — Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate. (Global Corporation) · FDA recall D-0387-2024
Lots / codes: Lot #: 123255, 123256, Exp. Date 11/2024; 123637, Exp. Date 03/2025 · reported Mar 20, 2024
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65131-097-12
Product NDC 65131-097
11-digit billing NDC 65131009712
UNII 362O9ITL9D, V1Q0O9OJ9Z
UPC 0805418097532
Application # M
SPL Set ID b7d3f54e-59ef-4b85-a88d-b053058dc1f6
Established class (EPC) Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-09-01
Route ORAL
Dosage form GRANULE, FOR SOLUTION
Substance ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE
Why two NDCs? The FDA registers this code as 65131-097-12 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 65131-0097-12. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

🧪 What is this product?

Broncochem Cold and Flu Tea is an over-the-counter oral granule product marketed under FDA's monograph rules for cold and flu symptom relief. The granules dissolve in hot water and contain acetaminophen, typically used to reduce fever and relieve minor aches and pain, and chlorpheniramine maleate, an antihistamine commonly used to help reduce sneezing and runny nose. This combination product is intended for people seeking multi-symptom cold and flu relief in a tea form.

Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 13 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
65131-0097-12 You're viewing this Main listing 25 PACKAGE in 1 BOX / 13 g in 1 PACKAGE 2017-09-28 — Active
65131-0097-53 65131-097-53 6 PACKAGE in 1 BOX / 13 g in 1 PACKAGE 2017-09-28 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 25 package in 1 box / 13 g in 1 package.
What NDC number is used to bill for this package of Broncochem Cold and Flu Tea Acetaminophen-Phenylephrine Hydrochloride-Chlorpheniramine Maleate 500 mg/13g; 4 mg/13g Granule, For Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Broncochem Cold And Flu Tea 500 mg/13g; 4 mg/13gthis 65131-0097-12 LABORATORIO 13 g — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2013
On the market since
Sep 2013
📍
2026
Currently FDA-listed
13 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color yellow
FlavorLime
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerLABORATORIO MAGNACHEM INTERNATIONAL SRL
FDA applicationM (OTC MONOGRAPH DRUG)
Labeler code65131
First marketedSep 2013
Product typeHuman Otc Drug
Portfolio13 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 177 words ▾

Indications and Usage Temporarily relieves these symptoms due to a cold: Minor aches and pains. Minor sore throat pain. Headache.

Nasal and sinus congestion. Runny nose. Sneezing Itchy nose or throat.

Itchy, watery eyes due to hay fever. Cough due to minor throat and bronchial irritation. Temporarily reduces fever.

Dosage and Administration Do not use more than directed. Take every 4 hours; do not take more than 6 packets in 24 hours unless directed by a doctor. Children under 4 years of age-Do not ue.

Children from 4 to 12 years of age-Do not use unless directed by a doctor. Adults and children 12 years of age and over-One packet Dissolve contents of one packet into 8 oz of hot or cold water, consume entire drink within 10-15 minutes. If using a microwave, add contents of one packet to 8 oz of cool wter stir briskly before and after heating.

Do not over heat. Inactive Ingredients Ascorbic acid, Silicon Dioxide, Citric Acid Monohydrate, Ethyl alcohol, Lime flavor, Maltodextrin, Sucrose, Honey, Sucralose, Tricalcium phosphate, Propyl gallate, Yellow No.5

⏱️ Dosage and Administration 128 words ▾

Dosage and Administration Do not use more than directed. Take every 4 hours; do not take more than 6 packets in 24 hours unless directed by a doctor. Children under 4 years of age-Do not ue.

Children from 4 to 12 years of age-Do not use unless directed by a doctor. Adults and children 12 years of age and over-One packet Dissolve contents of one packet into 8 oz of hot or cold water, consume entire drink within 10-15 minutes. If using a microwave, add contents of one packet to 8 oz of cool wter stir briskly before and after heating.

Do not over heat. Inactive Ingredients Ascorbic acid, Silicon Dioxide, Citric Acid Monohydrate, Ethyl alcohol, Lime flavor, Maltodextrin, Sucrose, Honey, Sucralose, Tricalcium phosphate, Propyl gallate, Yellow No.5

⚠️ Warnings ~1 min read ▾

Warnings Liver warning: This product contains acetaminophen, severe liver damage may occur if you take: More than 6 packets in 24 hours, which is the maximum daily amount. with other drugs containing acetaminophen. three (3) or more alcoholic drinks every day while using this product. Sore Tthroat warning: If sore throat is severe, persists for more than 2 days, is accompainied or followed by fever, headache, rash, nausea or vomiting consult a doctor promptly. Active Ingredients Acetaminophen.

Phenylephrine Hydrochloride. Chlorpheniramine Maleate Purpose Pain reliever/fever reducer Nasal decongestant Antihistamine Keep Out of the Reach of Children In case of overdose get medical help or contact a Poison Control Center right away, prompt medical attention is critical for adults as well as for children even if you do not notice any signs symptoms. Indications and Usage Temporarily relieves these symptoms due to a cold: Minor aches and pains.

Minor sore throat pain. Headache. Nasal and sinus congestion.

Runny nose. Sneezing Itchy nose or throat. Itchy, watery eyes due to hay fever.

Cough due to minor throat and bronchial irritation. Temporarily reduces fever. Dosage and Administration Do not use more than directed.

Take every 4 hours; do not take more than 6 packets in 24 hours unless directed by a doctor. Children under 4 years of age-Do not ue. Children from 4 to 12 years of age-Do not use unless directed by a doctor.

Adults and children 12 years of age and over-One packet Dissolve contents of one packet into 8 oz of hot or cold water, consume entire drink within 10-15 minutes. If using a microwave, add contents of one packet to 8 oz of cool wter stir briskly before and after heating. Do not over heat.

Inactive Ingredients Ascorbic acid, Silicon Dioxide, Citric Acid Monohydrate, Ethyl alcohol, Lime flavor, Maltodextrin, Sucrose, Honey, Sucralose, Tricalcium phosphate, Propyl gallate, Yellow No.5

🧪 Active Ingredient ~1 min read ▾

Active Ingredients Acetaminophen. Phenylephrine Hydrochloride. Chlorpheniramine Maleate Purpose Pain reliever/fever reducer Nasal decongestant Antihistamine Keep Out of the Reach of Children In case of overdose get medical help or contact a Poison Control Center right away, prompt medical attention is critical for adults as well as for children even if you do not notice any signs symptoms.

Indications and Usage Temporarily relieves these symptoms due to a cold: Minor aches and pains. Minor sore throat pain. Headache.

Nasal and sinus congestion. Runny nose. Sneezing Itchy nose or throat.

Itchy, watery eyes due to hay fever. Cough due to minor throat and bronchial irritation. Temporarily reduces fever.

Dosage and Administration Do not use more than directed. Take every 4 hours; do not take more than 6 packets in 24 hours unless directed by a doctor. Children under 4 years of age-Do not ue.

Children from 4 to 12 years of age-Do not use unless directed by a doctor. Adults and children 12 years of age and over-One packet Dissolve contents of one packet into 8 oz of hot or cold water, consume entire drink within 10-15 minutes. If using a microwave, add contents of one packet to 8 oz of cool wter stir briskly before and after heating.

Do not over heat. Inactive Ingredients Ascorbic acid, Silicon Dioxide, Citric Acid Monohydrate, Ethyl alcohol, Lime flavor, Maltodextrin, Sucrose, Honey, Sucralose, Tricalcium phosphate, Propyl gallate, Yellow No.5

🧪 Inactive Ingredients 23 words ▾

Inactive Ingredients Ascorbic acid, Silicon Dioxide, Citric Acid Monohydrate, Ethyl alcohol, Lime flavor, Maltodextrin, Sucrose, Honey, Sucralose, Tricalcium phosphate, Propyl gallate, Yellow No.5

🎯 Purpose ~1 min read ▾

Purpose Pain reliever/fever reducer Nasal decongestant Antihistamine Keep Out of the Reach of Children In case of overdose get medical help or contact a Poison Control Center right away, prompt medical attention is critical for adults as well as for children even if you do not notice any signs symptoms. Indications and Usage Temporarily relieves these symptoms due to a cold: Minor aches and pains. Minor sore throat pain.

Headache. Nasal and sinus congestion. Runny nose.

Sneezing Itchy nose or throat. Itchy, watery eyes due to hay fever. Cough due to minor throat and bronchial irritation.

Temporarily reduces fever. Dosage and Administration Do not use more than directed. Take every 4 hours; do not take more than 6 packets in 24 hours unless directed by a doctor.

Children under 4 years of age-Do not ue. Children from 4 to 12 years of age-Do not use unless directed by a doctor. Adults and children 12 years of age and over-One packet Dissolve contents of one packet into 8 oz of hot or cold water, consume entire drink within 10-15 minutes.

If using a microwave, add contents of one packet to 8 oz of cool wter stir briskly before and after heating. Do not over heat. Inactive Ingredients Ascorbic acid, Silicon Dioxide, Citric Acid Monohydrate, Ethyl alcohol, Lime flavor, Maltodextrin, Sucrose, Honey, Sucralose, Tricalcium phosphate, Propyl gallate, Yellow No.5

📄 Keep Out of Reach of Children 220 words ▾

Keep Out of the Reach of Children In case of overdose get medical help or contact a Poison Control Center right away, prompt medical attention is critical for adults as well as for children even if you do not notice any signs symptoms. Indications and Usage Temporarily relieves these symptoms due to a cold: Minor aches and pains. Minor sore throat pain.

Headache. Nasal and sinus congestion. Runny nose.

Sneezing Itchy nose or throat. Itchy, watery eyes due to hay fever. Cough due to minor throat and bronchial irritation.

Temporarily reduces fever. Dosage and Administration Do not use more than directed. Take every 4 hours; do not take more than 6 packets in 24 hours unless directed by a doctor.

Children under 4 years of age-Do not ue. Children from 4 to 12 years of age-Do not use unless directed by a doctor. Adults and children 12 years of age and over-One packet Dissolve contents of one packet into 8 oz of hot or cold water, consume entire drink within 10-15 minutes.

If using a microwave, add contents of one packet to 8 oz of cool wter stir briskly before and after heating. Do not over heat. Inactive Ingredients Ascorbic acid, Silicon Dioxide, Citric Acid Monohydrate, Ethyl alcohol, Lime flavor, Maltodextrin, Sucrose, Honey, Sucralose, Tricalcium phosphate, Propyl gallate, Yellow No.5

📄 Package Label / Principal Display Panel 39 words ▾

PACKAGE LABEL PRINCIPAL DISPLAY PANEL BOX - BRONCOCHEM COLD & FLU TEA_6 Packs.jpg

PACKAGE LABEL PRINCIPAL DISPLAY PANNEL BOX - BRONCOCHEM COLD & FLU TEA _25 Packs-01.jpg

PACKAGE LABEL PRINCIPAL DISPLAY PANEL LABEL - BRONCOCHEM COLD & FLU TEA-01.jpg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by LABORATORIO MAGNACHEM INTERNATIONAL SRL. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 13 g (65131-0097-53). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
LABORATORIO MAGNACHEM INTERNATIONAL SRL is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.